Medical Marijuana: Advocates are pushing forward a California ballot initiative that would create a Board of Medical Marijuana Enforcement to oversee the state’s burgeoning industry, Lisa Leff reports for the Associated Press. We’re imagining the snacks at board meetings.
Health Reform: California Healthline’s Dan Diamond highlights five health reform issuesfor reporters and policymakers to watch closely in 2012. First among them: the Supreme Court review of health reform’s constitutionality.
Medicare: Scammers create intricate webs of Read more »
*This blog post was originally published at Reporting on Health - The Reporting on Health Daily Briefing*
Kim Jong Il: Of course we’re going to highlight the lowlights of the North Korean leader’s health: CNN has the scoop on the dictator’s cause of death and previous illnesses. Knight Science Journalism Tracker’s Paul Raeburn rounds up previous analyses of Kim Jong Il’s psychological profile.
Breast Cancer: Companies are trying to build a better mammogram as they compete for a bigger slice of the $6 billion-and-growing medical imaging market, Sierra Jiminez reports for Fortune. Nearly 300,000 American women have been diagnosed with breast cancer this year.
Health Reform: The U.S. Supreme Court will devote an unprecedented week of oral argument over health reform when Read more »
*This blog post was originally published at Reporting on Health - The Reporting on Health Daily Briefing*
The Supreme Court has sided with Big Pharma in their challenge to the Vermont Law limiting the pharmaceutical Industry’s access to physician prescribing information.
The nation’s high court handed down a verdict Thursday in the Sorrell v. IMS Health case, striking down by a 6-3 vote a 2007 Vermont law that that bans the practice of data mining — the sale and use of prescriber-identifiable information for marketing or promoting a drug, including drug detailing — unless a physician specifically gives his or her permission to use the information.
Apparently, Big Pharma’s right to “free speech” trumps my right to privacy. How getting access to my prescribing information has anything to do with free speech is beyond me. In the twisted logic of the pro-business, anti-citizen Supreme Court –
Speech in aid of pharmaceutical marketing… is a form of expression protected by the Free Speech Clause of the First Amendment. Read more »
*This blog post was originally published at The Blog That Ate Manhattan*
The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.
In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug – Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.
I reached out to Wyeth’s attorney, Bert Rein, for comment. Here’s a podcast of our interview:
Here are the highlights from the interview…
Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?
Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.
Dr. Val: So basically this means that juries can decide whether or not a drug label is sufficiently caveated?
Rein: It goes farther than that. Juries don’t have to determine what the label should say, they merely have to decide that the label isn’t “good enough.”
Dr. Val: So jurors without any medical background are supposed to determine whether or not a drug label offers physicians sufficient warning about medication risks?
Rein: Correct. You’re asking lay people not only to make the decision, but to step into the shoes of physicians and say, “Do I think that label is good enough from a physician’s point of view?” By definition, drug labels are not written for lay people, but healthcare professionals. This is asking a lot of lay people, and I think this case is a good illustration of why juries get it wrong. They see an injured person and say “How could the labeling be adequate because somebody’s been hurt?”
Dr. Val: What impact will this court ruling have on the pharmaceutical industry?
Rein: It means that pharmaceutical companies will have to get “clear records” from the FDA on every drug label controversy going forward. This puts a tremendous burden on their already taxed resources. Also if juries can simply say “this drug label is inadequate” then how will the drug company know how to make it better? What drug companies will have to do is forbid the administration of drugs in circumstance that might incur increased risk. That shifts liability to the physician if they administer the drug outside of the prescribed method – and essentially makes the risk benefit decisions on their behalf.
Dr. Val: So won’t drug companies have to create really long drug inserts to prevent juries from misunderstanding the language?
Rein: Yes, that’s the direction that labels were going before the FDA tried to reform the system. When drug labels are that long, no one reads them. Then professionals really don’t get educated on the true risks and benefits of the drug. Long labels are not designed for provider education but for law suits. Jury dominance always results in risk aversion.
Dr. Val: And isn’t this risk aversion going to slow down the drug approval process in general?
Rein: The industry shies away from developing drugs that have massive liability. That’s why we don’t develop drugs for pregnant women, for example. Any time you unleash a potent liability system, it’s going to factor in to where research dollars are spent. The more the FDA is criticized, the more it tries to protect itself with long drug labels – which ends up slowing down the drug approval process and shifting liability to doctors.
Dr. Val: And phenergan has been safely administered over 200 million times… and so the risk aversion is pretty high, even now with this rather safe drug.
Rein: Right, it’s not as if the drug is rampantly causing injury. Twenty incidents out of 200 million applications is not a very high risk profile. And the few cases where it caused injury, the drug was administered incorrectly. But if you have an injured person sitting in front of a jury of lay people, it seems as if the logical conclusion is that if the warnings were adequate, this wouldn’t have happened.
If we take the American Foundation for Justice at its word, their next move is to try to change the law on medical devices so we can go after those as well. The Wyeth vs. Levine case is good for one industry – the lawsuit industry – and not really anyone else.
The Supreme Court decision text may be found here.
For some reason, people just love to misrepresent the issues underlying the Wyeth vs. Levine case. I have written extensively about this case here and here because I found it so amazing that the media has bungled the story so badly – and that no one is really calling them on it.
In case you don’t recall – Ms. Levine was the victim of medical malpractice. An anti-nausea drug (phenergan) was injected into (or very near) her artery by accident (the potential consequences of such an error are clearly indicated on the drug label). Tragically, the resulting chemical reaction with the oxygen in her artery caused such severe tissue irritation that her arm eventually had to be amputated. Ms. Levine settled out of court for $700,000 with the clinic where the injection occurred. Unfortunately the story doesn’t stop there.
Ms. Levine’s attorney counseled her to sue the drug manufacturer for inadequate label warnings (the potential hazard is in fact mentioned on the label six times – though it does not forbid IV administration of the drug, though it recommends a low dose and slow push). In a precedent-setting judgment, a jury in Vermont decided that the FDA-approved label was inadequate, and that it should have fully contraindicated administration via IV push. The jury awarded Ms. Levine $6.8 million and Wyeth contested the judgment, bringing the case to the US Supreme court in November, 2008. The case has not yet been decided, though it has been compared to deceptive labeling of “light cigarettes.”
How on earth is a drug that has been successfully administered (without harmful side effects and with good efficacy) over 200 million times in the U.S. equivalent to cigarettes (a known carcinogen with no therapeutic value)? It’s an exceedingly poor analogy.
To put it another way, if a nurse took an insulin syringe and injected it into a diabetic’s eyeball, causing blindness, should I say that the insulin manufacturer (because it did not forbid the injection into the eye) was engaging in deceptive labeling and should be at fault for the patient’s loss of vision? The PA who injected the phenergan into Ms. Levine’s artery, and our hypothetical nurse who injected insulin into an eyeball are the ones to blame.
But wait, it gets worse.
The attorney (David C. Frederick) who is arguing Ms. Levine’s case in front of the Supreme Court is being considered by our President elect for the position of Solicitor General of the United States. Yes, this very man who is engaged in a law suit that could potentially set a precedent that would allow all 50 states to set up their own mini-FDAs with the lay public (i.e. juries) deciding what drug label language should say.
The pro-Levine camp argues that a court ruling in favor of Wyeth would preempt consumers from being able to sue drug companies for damages related to incomplete disclosure of risks (such as the Vioxx case) but in reality, the Wyeth vs. Levine case has no bearing on pharmaceutical non-disclosure, since Wyeth did not hide the irritant risks of phenergan from the FDA. They have been known for decades.
So Wyeth vs. Levine is NOT about deceptive labeling or non-disclosure of risks – it’s about whether medically uneducated juries should have the power to set arbitrary drug labeling language standards in order to facilitate litigation against deep-pocketed pharmaceutical manufacturers whenever a patient is harmed in a case of medical malpractice.
I understand that many folks are frustrated with pharmaceutical wrong doing (and there are many cases of it), but this is just not one of them. In America, we are not supposed to bring pre-conceived notions to bear on law suits, but objectively review the facts in each case, separate from our general feelings about those involved. I do think that Wyeth isn’t getting a fair shake in the media because of the general mistrust/dislike of Big Pharma. But everyone has a right to a fair trial. I sure hope they get it.